1. Handling Hazardous Drugs Pharmacy Benefits Management Drug Accountability Conference May 13, 2010, San Antonio, TX George Knight, RPh VISN 2 Network Pharmacy Executive/PBM Manager In Collaboration with Kevin Hartman, CHMM Environmental Engineer, Syracuse VAMC

2. Hazardous Waste Training for Healthcare Workers – What’s Up? The EPA considers some chemicals, including some drugs, to be hazardous waste when discarded. Having Addressed the Manufacturing Industry, the EPA is Now Focusing on the Health Care System as the Next Largest Contributing Factor to Environmental Contamination.

3. Why the Focus on Pharmaceuticals? They are being found in the environment and in our public water works. Regulatory emphasis by all levels of the EPA (local, state and federal) Standards require compliance with regulations; Joint Commission, CAP, CARF … VA Directive 2003-030 Management of Hazardous Chemicals

4. CARTOON: “I’m going to prescribe a birth control pill and an antibiotic and a tranquilizer! Or you can drink two quarts of tap water and call me in the morning!”

5. Potential Problems Increased Occurrence of Cancer Unusual Physiological Processes (Reproductive Impairment) Antibiotic-Resistant Bacteria Augmented Toxicity of Chemical Mixtures

6. Not just a fish story…

7. How is Pharmaceutical Waste Generated? IV Preparation General compounding Spills/breakage Partially used vials/syringes Discontinued/unused Unused repacks (unit dose) Patient’s personal medications Outdated pharmaceuticals

8. Health Care Facilities Must Follow the Hazardous Waste Regulations Proper Identification Segregation & Storage Manifesting and Transporting Proper Disposal, i.e. Incineration at a Federally Permitted Incineration Site

9. Resource Conservation and Recovery Act (RCRA) RCRA Regulates the Disposal of Solid Wastes Enforced by the EPA and the States Defines Hazardous Waste and Procedures for Handling and Disposal of Wastes Most States have a Hazardous Waste Program approved by the EPA

10. EPA Universal Waste Rule Proposed Addition of Hazardous Pharmaceutical Waste to the Universal Waste Rule Streamlined Management Encourage Disposal of Non-Hazardous Pharmaceuticals as Universal Waste Facilitate Collection of Personal Medications from the Public Michigan and Florida have done this at the State Level

11. Categories of RCRA Hazardous Wastes: P-Listed Acutely Hazardous Sole Active Ingredient - Unused Empty – Only if Triple Rinsed Rinse Solution is Hazardous, or …. Manage Un-rinsed Containers as Hazardous (vials, IV tubing)

12. Examples of P-Listed Wastes Arsenic Trioxide (Chemotherapy) Epinephrine (Excluded if in used syringe; may be discarded as regulated medical waste) ** not EPI salts ** except MN Nicotine (patch backing but not wrappers) Warfarin > 0.3% (all Rx dosages) Nitroglycerine (Excluded federally and some states if in final dosage form) Phentermine (1 of 2 Controlled Substances)

13. Categories of RCRA Hazardous Wastes: U-Listed Toxic - not as disastrous as P Sole Active Ingredient - Unused Empty Containers All contents have been removed through normal means and < 3% by weight remains = not hazardous Residues removed from containers must be managed as hazardous waste

14. Examples of U-Listed Wastes Chloral Hydrate (2 nd CS) Chlorambucil Lindane Warfarin < 0.3% (all Rx dosages exceed this percentage) Saccharin

15. Categories of RCRA Hazardous Wastes: Characteristic (D-Listed) Pharmaceutical, chemical formulations not on P-List or U-List, which exhibit one or more of the following characteristics: Ignitability (nitroglycerin inj.) Toxicity (M-cresol or thimerosol as preservative; fluvax; reserpine) Corrosivity Reactivity

16. Examples of D-Listed or Characteristic Wastes Used or Unused, but only when present in concentrations at or above the indicated RCRA regulatory level: Chloroform – 6.0 mg/L Mercury – 0.2 mg/L; contains thimerosol and fails this threshold Silver – 5.0 mg/L; silver nitrate applicators Selenium – 1.0 mg/L; Selsun Blue

17. When is an Outdated Drug a Waste? At the time and place the decision is made to discard it If a Reverse Distributor is used and the decision to discard is made there – we are still the generator of the waste. We can ship creditable outdates to a reverse distributor as product. All non-credit materials must be handled as hazardous waste on-site, once we know they are not creditable. Keep a list.

18. Uncreditable Items ManufacturerProductForm IVAX PHARMACEUTICALS, INC.ALBUTEROLAERO AMERICAN REGENT LABS, INC.ALCOHOL DEHYDRATEDSOL APLICARE, INC.APLICARE IODOPHOR PVP PREPPAD BOEHRINGER INGELHEIMATROVENTAERO THE PURDUE FREDERICK COMPANYBETADINEOINT HUMCOCOLLODION FLEXIBLESOL

19. Pharmacy/Ward Procedures P-Listed: Use Black Container U-Listed: Use Black Container D-Listed: Use Black Container Unlisted: Use Red Container Regulated Medical Waste Un-creditable pharmacy returns

20. Labeling & Education Black Dot Labeling; U-Listed & Characteristic (D-Listed) Caution Label; Special Disposal Required P- Listed + containers Med Cart Containers Listing by Location Develop a Comprehensive Facility and Departmental SOP

22. Formulary List CYCLOPHOSPHAMIDE INJECTIONBlack DotToxic [U058]U-list CYCLOPHOSPHAMIDE TABLETSBlack DotToxic [U058]U-list DAUNORUBICIN INJECTIONBlack DotToxic [U059]U-list DEXAMETHASONEBlack DotFlammable [D001]Characteristic DIETHYLSTILBESTROL TABBlack Dot Toxic [U089- Diethylstilbestrol]U-list WARFARIN SODIUMCaution Toxic [P001-Warfarin] Conc. > 0.3%P-list

23. Chemotherapy Waste (U-Listed) Two waste streams for this waste are required Trace Waste (Yellow chemo containers in Pharmacy) EMPTY vials, syringes, IV bags. Soft waste: gowns, gloves, goggles, tubing and wipes UNLESS overtly contaminated, container holding any amount of free liquid, overtly contaminated garments and spill cleanup kits.

24. Chemotherapy Waste (U-Listed) Bulk Waste Containers EMPTY vials, syringes, IV bags. A container holding any amount of free liquid, overtly contaminated garments and spill cleanup kits. Only style used on the Nursing units

25. Chemo Waste Containers Bulk Chemo = Hazardous Waste Unused/partially used vials, or IV’s; Vials or IV’s with ANY amount of free liquid; grossly contaminated items; and spill clean up materials Trace Chemo Waste Empty vials, syringes, IVs, tubing, gowns, gloves,etc.

26. Satellite Accumulation Good Idea to Label as Satellite Accumulation Must have the words “hazardous waste” Must have a clear description of the waste Date not required Satellite Accumulation Acetone & methanol

27. Labeling Requirements (Storage Area) The words “Hazardous Waste” must be on the container. Clear description of the waste type must be neatly printed on the label. Accumulation start date for 90 or 180 day areas.

28. Generator Status Large Quantity Generator > 2.2 lbs. “P” > 2200 lbs./mo. non-acute Small Quantity Generator < 2.2 lbs. “P” < 2200 lbs./mo. non-acute

29. Additional Points Incompatible wastes must be properly segregated. Weekly inspections are required to be documented for all long term hazardous waste storage areas (90 or 180 day areas).

30. Additional Points Must have spill response equipment & containment equipment in the area Secondary containment is required to prevent uncontrolled spills Training requirements for long term storage areas Within 6 months Annual requirement "Cradle-to-grave" responsibility

31. Consequences of Non-Compliance Compliance inspections Fines/penalties License revoked Criminal citations Civil actions Imprisonment Corrective orders 08/18/2009 Department of Veterans Affairs Eastern Kansas Health Care System Civil Penalty $51,501 Department of Veterans Affairs Eastern Kansas Health Care System VA must also spend at least $482,069 on management project. Recent Example

32. REGULAR TRASH Packaging Empty bottles Paper Plastic Recycle whenever possible SEWER SYSTEM Non-Haz IV’s (NaCl, D5W) User must evaluate if the liquid is or is not a hazardous waste**. ** Other items that our Sewer Use Permit allows HAZARDOUS WASTE P-Listed + Their Containers U-Listed Characteristic waste This waste stream must be properly segregated, labeled and stored. Includes pharmaceutical wastes Turn into the Environmental Engineer ext. 12345 for disposal at a State or Federally Permitted Hazardous Waste Facility CHEMO WASTE This stream is divided in two 1) Trace Chemo Waste 2) Bulk Chemo Waste 1) Trace is sent to a Medical Incinerator 2) Bulk follows the requirements of the Hazardous Waste Stream. Unused NonHaz Rx Collected in pharmacy. Returned for credit through Reverse Distribution. SHARPS Empty non-chemo & non-P-listed Ampoules Empty non-chemo & non-P-listed needle-syringes Note Federal Exemption for used Epinephrine syringes - treat as a sharp Managing Our Waste Streams

33. Vials or IV’s with ANY amount of liquid; Grossly contaminated items; Spill clean up materials. Bulk Chemo Pharmaceuticals may not be disposed of down the sink, sewer, or toilets without special permission from the Environmental Engineer and Pharmacy. DEA Controlled Drugs: follow proper protocol for disposal of these items. Contact Radiation Safety Officer Radiation Paper, Glass, Plastic, Metal, Toner Cartridges, Batteries, Newspaper, Electronics, Computers, Furniture Empty non- chemo & non-P- listed Ampoules Empty non- chemo & non-P- listed syringes **Note Federal Exemption for Empty Epinephrine syringes - treat as a sharp Bloody Regulated Body Fluids (e.g. joint fluid) Laboratory Waste ANY Unused or partially used Med. Spill cleanup aerosol cans Special attention to: Epinephrine: including empty IV bags, tubing, ampoules, and vials. Nicotine: including wrappers Warfarin: including empty wrappers and containers Empty vials, syringes, IVs, tubing, gowns, gloves, etc. Contact Environmental Engineer Non-haz IV’s (NaCl, D5W) **Other items that our Sewer Use Permit allows** Packaging Empty bottles* Paper Plastic Know Where to Throw RecyclingSharpsBio Hazard Waste Pharmaceuticals Trace ChemoHazardous Waste SewerTrash Know Where to Throw

34. Questions, comments, concerns? Be sure to evaluate your area Do you have waste that has not been evaluated (cleaning rags, other chemicals, equipment that automatically dumps into the sewer system)? Do you have ample/proper spill kits? Do you have proper postings? Emergency contacts, spill plans, exit routes….